Tooth Whiteners & Oral Hygiene Products containing hydrogen peroxide

8. Conclusion – Are oral hygiene products and tooth whiteners containing hydrogen peroxide safe and should they be freely available to consumers?

The SCCP opinion states:

4.CONCLUSION

In response to the questions asked, the SCCP is of the opinion
that for practical reasons, the following
concentration limits of
hydrogen peroxide, when
used in oral hygiene and tooth whitening products, should be
considered: up to 0.1%, up to 6% (Higher
concentrations may be used
provided that the total amount of hydrogen peroxide is equal or
lower than in products using 6% hydrogen peroxide and 0.2 g gel
load and that studies have demonstrated that the concentration
of hydrogen peroxide in the saliva and on the gingiva is not
higher than in products containing 6% hydrogen peroxide), and
more than 6%. The limit of 0.1% is based on a level at which
there is no risk to the consumer from the use of hydrogen
peroxide in oral hygiene and tooth whitening products under
normal or reasonable foreseeable conditions of use. In
toothpastes and mouth rinses, the hydrogen peroxide
concentration should not exceed 0.1% (SCCNFP/0158/99). The limit
of 6% for tooth whitening products refers to the limit given in
the Terms of Reference in relation to the Opinion SCCP/0844/04.
It should also be noted that for hydrogen peroxide
concentrations above 6%, the MOS will be below 100; therefore,
products containing more than 6% hydrogen peroxide are not safe
for use by the consumer.

The present opinion refers to the
concentration of
hydrogen peroxide in its
free form or when released (some hydrogen peroxide releasing
substances may not be specifically mentioned in this opinion).
In the case of the substances discussed in Appendix (sodium
percarbonate, sodium perborate, and potassium
peroxymonosulphate), it refers to the
concentrations of the
substances that will result in the same amount of hydrogen
peroxide or reactive oxygen species being available as the
specified concentrations of hydrogen peroxide above.

Based on the available data, the SCCP is not in a
position to define a level of
hydrogen peroxide and a
frequency of application that would result in
exposure which would be
considered safe for the consumer.

With increasing
concentration of
hydrogen peroxide and frequency of application there will be
an increasing risk associated with the use of these
products. It cannot be anticipated what the exposure would
be if the products were to be freely and directly available
to the consumer.

Potential risks associated with the use of products
containing more than 0.1% and up to 6% hydrogen peroxide may
be reduced if:

Potential risks associated with the use of products
containing more than 0.1% and up to 6%
hydrogen peroxide may
be reduced if:

a) used only after clinical examination to ensure the absence
of risk factors identified below or other oral pathology of
concern.

Particular care should be taken in using tooth
whitening products by persons with gingivitis and other
periodontal diseases or defective restorations. Conditions
such as pre-existing oral
tissue injury or
concurrent use of tobacco and/or
alcohol may exacerbate
the toxic effects of
hydrogen peroxide (see
e.g. section 3.3.15).

Their use is not recommended prior to or immediately
after dental restoration.

b) exposure to
tooth whitening products containing 0.1 to 6%
hydrogen peroxide is to be
limited in a manner that ensures that the products are used only
as intended in terms of frequency and duration of application to
avoid reasonably foreseeable misuse

There is an absence of good clinical data and
long-term
epidemiological studies
that assess the possible adverse effects within the oral
cavity (see SCCP/0974/06). The SCCP recommends that, in
consideration of public health, independent long-term safety
evaluations should be performed (see
SCCP/0974/06).

In the absence of specific data on the safety of tooth
whitening products in children/adolescents, the SCCP is not
in a position to assess the potential health risks
associated with their use in this
population
subgroup.